Using BHB with CAR-T therapy for lymphoma treatment
Preliminary Investigation of β-hydroxybutyrate Supplementation for Lymphoma Patients Receiving Anti-CD19 CAR T-cells
This study is testing if taking a supplement called BHB while getting CAR-T therapy for large B-cell lymphoma can be safe and help improve the treatment's effects on the body.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abramson Cancer Center at Penn Medicine Academic / other |
| Drugs / interventions | CAR-T, CAR T |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06610344 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of β-hydroxybutyrate (BHB) supplementation in patients undergoing treatment for large B-cell lymphoma with anti-CD19 CAR T-cells. Participants will receive oral BHB supplementation through HVMN Ketone-IQ while receiving standard CAR-T therapy. The study aims to assess whether BHB affects the gut microbiome and peripheral blood mononuclear cells (PBMCs) in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed large B-cell lymphoma who are eligible for anti-CD19 CAR-T therapy.
Not a fit: Patients who are not eligible for CAR-T therapy or have contraindications to BHB supplementation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of CAR-T therapy for lymphoma patients.
How similar studies have performed: While the combination of BHB supplementation with CAR-T therapy is a novel approach, similar studies exploring metabolic interventions in cancer treatment have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age of 18 years or older * History of pathologically-confirmed large B-cell lymphoma (LBCL) * Planned treatment with a commercially available anti-CD19 CAR-T product (Yescarta or Kymriah) * Eligible for and with adequate organ function (investigator discretion) and performance status (ECOG PS 2 or less) for standard of care, anti-CD19 CAR-T * Not enrolled on a clinical trial of bridging therapy prior to CAR-T * Patients must have a PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra- nodal lesions in largest dimension by low-dose computerized tomography \[CT\] scan with FDG-uptake ≥ liver) documented prior to leukapheresis for CAR-T manufacturing * Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator * Can provide informed consent * Willing to comply with all study procedures and available for the duration of the study Exclusion Criteria: * Subject is pregnant or breast feeding * History of allergy to energy drinks * History of inflammatory bowel disease * History of type 1 diabetes mellitus or requirement for insulin * History of chronic kidney disease with an eGFR \< 30 mL/min/1.73m2 * Additional second primary malignancy for which the subject is receiving active therapy or that will impede the ability of the investigator to assess lymphoma response
Where this trial is running
Philadelphia, Pennsylvania
- Abramson Cancer Center at University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Elise Chong, MD — Abramson Cancer Center at the University of Pennsylvania
- Study coordinator: Brittany Koch, MPH
- Email: Brittany.Koch@pennmedicine.upenn.edu
- Phone: 215-615-4312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.